Health Canada grants priority review for Novartis’ heart failure medicine LCZ696

CADTH

Novartis Pharmaceuticals Canada Inc. announced today that Health Canada has granted priority review for the New Drug Submission (NDS) by Novartis for LCZ696, an investigational medicine for the treatment of heart failure (NYHA class II-IV) with systolic dysfunction (reduced ejection fraction) (HFrEF).

Priority review is granted by Health Canada following a preliminary review of clinical data when a new treatment appears to have the potential to offer significant clinical benefit, defined as “outcomes that have an overall positive impact on the treatment” of diseases that are “serious, life-threatening or severely debilitating”5.

Heart failure is one of the leading causes of death in Canada6 and the second leading cause of hospitalization of Canadians age 65 or older7. Priority review by Health Canada means the review could be completed in about seven months from the date of submission8.

“We are very pleased that Health Canada has granted LCZ696 priority review” said Tim Maloney, President of Novartis Pharmaceuticals Canada Inc. “We look forward to cooperating with Health Canada in its review of the file and to making LCZ696 available to Canadian patients as soon as possible.” 

For more details, go to: http://www.novartis.ca/cs/www.novartis.ca-v2/downloads/en/News/LCZ696_Priority_Review_Media_Release_March_12.pdf

Michael Wonder

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Michael Wonder

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